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Analysis of the Formula Design and Applications of Four Approved Thickening Components

from CIRS by

As of now, China has officially approved four thickening component formulas for special medical purposes designed for individuals over 10 years old with swallowing difficulties and/or aspiration risks, all of which were approved in the past two years.

All four products are domestically produced and are in powdered form. Each of the following companies – Jilin Maifu, Hebei Aisheng, Shandong Ruoyao, and Jiangsu Daisy FSMP – has had one formula approved.

China,Food,FSMP,Application,Special,Medical,Purpose

Table 1. List of four approved thickening components

S.N.

Applicant

Product name

Dosage form

Registration number

Ingredient list

1

Jilin Maifu

Maifu Shun Bao (麦孚顺宝®)

Powder

TY20230026

Maltodextrin, Xanthan gum, Erythritol, Guar gum, Sodium alginate

2

Hebei Aisheng

Nuo Bao Chang

(诺葆畅®)

Powder

TY20240012

Maltodextrin, Xanthan gum

3

Shandong Ruoyao

Ruo Ning

(若宁)

Powder

TY20240021

Maltodextrin, Guar gum, Gellan gum, Carrageenan, Xanthan gum

4

Jiangsu Daisy FSMP

Dong Ze Li Shun (冬泽力顺)

Powder

TY20240031

Xanthan gum, Maltodextrin

The thickening components are based on carbohydrates and incorporate one or more thickeners, with dietary fiber optionally added. Among the four approved products, all use maltodextrin as the carbohydrate source, combined with one or more thickeners to enhance thickening performance and expand their applicability. Only one product includes dietary fiber in its formula.

Maltodextrin is widely used in thickening components for special medical purposes due to its recognized safety and stability. Its excellent properties, such as rapid dissolution, low moisture absorption, resistance to clumping, and good taste, make it a preferred choice. Additionally, its relatively low cost offers significant cost-effectiveness for large-scale applications.

Table 2. Dysphagia food levels corresponding to the product after preparation with water

Product name

Maifu Shun Bao (麦孚顺宝®)

Nuo Bao Chang (诺葆畅®)

Ruo Ning (若宁)

Dong Ze Li Shun (冬泽力顺)

Water amount

200mL

200mL

400mL

100mL

Use level

1g

2.5g

5g

10g

2g

4g

6g

1.5g

3.0g

6.0g

0.2g

0.4g

0.8g

3g

Type

Slightly thick

Mildly thick

Moderately thick

Extremely thick

Mildly thick

Moderately thick

Extremely thick

Slightly thick

Moderately thick

Extremely thick

Slightly thick

Mildly thick

Moderately thick

Extremely thick

IDDSI level*

1

2

3

4

0+1

2

3

2

3

4

1

2

3

4

* The International Dysphagia Diet Standardisation Initiative (IDDSI)

Table 3. IDDSI levels

Level

Description/characteristics

Physiological rationale for this level of thickness

IDDSI Flow Test/Others

0: Thin

1. Flows like water;

2. Fast flow; and

3. Can drink it through any type of teat, cup or straw as appropriate for age and skills.

Functional ability to safely manage liquids of all types.

Less than 1 mL remaining in the 10 mL slip tip syringe after 10 seconds of flow

1: Slightly thick

1. Thicker than water;

2. Requires a little more effort to drink than thin liquids;

3. Flows through a straw, syringe, teat; and

4. Similar to the thickness of most commercially available “Anti-regurgitation” (AR) infant formulas.

1. Often used in the paediatric population as a thickened drink that reduces speed of flow yet is still able to flow through an infant bottle teat. Consideration to flow through a teat should be determined on a case-by-case basis;

2. Also used in adult populations where thin drinks flow too fast to be controlled safely. These slightly thick liquids will flow at a slightly slower rate.

Test liquid flows through a 10 mL slip tip syringe leaving 1-4 mL in the syringe after 10 seconds

2: Mildly thick

1. Flows off a spoon;

2. Sippable, pours quickly from a spoon, but slower than thin drinks; and

3. Mild effort is required to drink this thickness through standard bore straw (standard bore straw = 0.209 inch or 5.3 mm diameter).

1. If thin drinks flow too fast to be controlled safely, these Mildly Thick liquids will flow at a slightly slower rate;

2. May be suitable if tongue control is slightly reduced.

Test liquid flows through a 10 mL slip tip syringe leaving 4 to 8 ml in the syringe after 10 seconds

3: Moderately thick/

liquidised

1. Can be drunk from a cup;

2. Moderate effort is required to suck through a standard bore or wide bore straw (wide bore straw = 0.275 inch or 6.9 mm);

3. Cannot be piped, layered or molded on a plate because it will not retain its shape;

4. Cannot be eaten with a fork because it drips slowly in dollops through the prongs;

5. Can be eaten with a spoon;

6. No oral processing or chewing required – can be swallowed directly; and

7. Smooth texture with no ‘bits’ (lumps, fibers, bits of shell or skin,husk, particles of gristle or bone).

1. If tongue control is insufficient to manage Mildly Thick drinks (Level 2), this Liquidised/Moderately thick level may be suitable;

2. Allows more time for oral control;

3. Needs some tongue propulsion effort; and

4. Pain on swallowing.

Test liquid flows through a 10 ml slip tip syringe leaving > 8 ml in the syringe after 10 seconds

4: Extremely thick/

pureed

1. Usually eaten with a spoon (a fork is possible);

2. Cannot be drunk from a cup because it does not flow easily;

3. Cannot be sucked through a straw;

4. Does not require chewing;

5. Can be piped, layered or molded because it retains its shape, but should not require chewing if presented in this form;

6. Shows some very slow movement under gravity but cannot be poured;

7. Falls off spoon in a single spoonful when tilted and continues to hold shape on a plate;

8. No lumps;

9. Not sticky; and

10. Liquid must not separate from solid.

1. If tongue control is significantly reduced, this category may be easiest to control;

2. Requires less propulsion effort than Minced & Moist (level 5), Soft & Bite-Sized (Level 6), and Regular and Regular Easy to Chew (Level 7) but more than Liquidised/Moderately thick (Level 3);

3. No biting or chewing is required• Increased oral and/or pharyngeal residue is a risk if too sticky;

4. Any food that requires chewing, controlled manipulation or bolus formation are not suitable;

5. Pain on chewing or swallowing; and

6. Missing teeth, poorly fitting dentures.

n/a. The IDDSI Flow test is not applicable

5: Minced & moist

1. Can be eaten with a fork or spoon;

2. Could be eaten with chopsticks in some cases, if the individual has very good hand control;

3. Can be scooped and shaped (e.g. into a ball shape) on a plate;

4. Soft and moist with no separate thin liquid;

5. Small lumps visible within the food

  • Paediatric, equal to or less than 2mm width and no longer than 8mm in length
  • Adult, equal to or less than 4mm width and no longer than 15mm in length

6. Lumps are easy to squash with tongue.

1. Biting is not required;

2. Minimal chewing is required;

3. Tongue force alone can be used to separate the soft small particles in this texture;

4. Tongue force is required to move the bolus;

5. Pain or fatigue on chewing;

6. Missing teeth, poorly fitting dentures.

Use chopstick test, finger test, and spoon tilt test.

6: Soft &

Bite-sized

1. Can be eaten with a fork, spoon or chopsticks;

2. Can be mashed/broken down with pressure from fork, spoon or chopsticks;

3. A knife is not required to cut this food, but may be used to help load a fork or spoon;

4. Soft, tender and moist throughout but with no separate thin liquid;

5. Chewing is required before swallowing;

6. ‘Bite-sized’ pieces as appropriate for size and oral processing skills

  • Paediatric, 8mm pieces (no larger than)
  • Adults, 15mm = 1.5 cm pieces (no larger than)

1. Biting is not required;

2. Chewing is required;

3. Food piece sizes designed to minimize choking risk;

4. Tongue force and control is required to move the food and keep it within the mouth for chewing and oral processing;

5. Tongue force is required to move the bolus for swallowing;

6. Pain or fatigue on chewing; and

7. Missing teeth, poorly fitting dentures.

Fork pressure, chopstick, and finger test

7: Easy to chew

1. Normal, everyday foods of soft/tender textures that are developmentally and age appropriate;

2. Any method may be used to eat these foods;

3. Sample size is not restricted at Level 7, therefore, foods may be of a range of sizes

  • Smaller or greater than 8mm pieces (Paediatric)
  • Smaller or greater than 15mm = 1.5 cm pieces (Adults)

4. Does not include: hard, tough, chewy, fibrous, stringy, crunchy, orcrumbly bits, pips, seeds, fibrous parts of fruit, husks or bones.

1. Requires the ability to bite soft foods and chew and orally process food for long enough that the person forms a soft cohesive ball/bolus that is ‘swallow ready’. Does not necessarily require teeth.;

2. Requires the ability to chew and orally process soft/tender foods without tiring easily; and

3. May be suitable for people who find hard and/or chewy foods difficult or painful to chew and swallow.

/

The four approved formulas are classified according to the international IDDSI standards. This makes it easier for doctors and nutritionists to guide the usage based on the patient’s age, weight, and medical condition, in order to to thicken foods, reducing the risk of leftover residue and aspiration during swallowing. In China, there are also relevant standards, such as the Chinese Expert Consensus on Nutritional Management of Dysphagia Diets (2019 Edition). It classifies liquid foods into three levels: Level 1 (mildly thick), Level 2 (moderately thick), and Level 3 (extremely thick). Solid foods are classified into three levels as well: Level 4 (pureed), Level 5 (minced and moist), and Level 6 (soft and bite-sized).

The nutrient content of the four approved formulas is as follows:

Table 4. Nutrient content results

Nutrient

Unit

Content

Energy

kJ/100g

1186~1539

Protein

g/100g

0.3~2.5

Fat

g/100g

0

Carbohydrate

g/100g

53.7~90

Sodium

mg/100g

180~465

Dietary fiber

g/100g

31.5

When designing the thickening components, companies must follow the national food safety standards, choose appropriate ingredients, and thoroughly evaluate the thickening effects, consumption methods, and the resulting consistency after preparation.

For more information about the registration of FSMP in China, please click here to learn about our FSMP registration service.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

  

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